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EUDAMED Deadline Approaching: Ensure Your UDI Data Is Ready Before May 2026
Prepare your product data for EUDAMED faster with a platform that validates, formats, and submits UDI data automatically. Manage and syndicate medical device data to EUDAMED and other global registries from one system.
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Is your team ready for EUDAMED 2026? Learn what to do in our free webinar
The Most Common UDI Data Management Challenges
Regulatory Database Variability
Each regulatory authority maintains its own database, with different formats, structures, and requirements, making accurate and timely submissions a constant challenge.
Complex Data Submission Processes
Submitting product information through regulatory interfaces is often cumbersome, error-prone, and lacks user-friendly guidance.
Product Data Inconsistency
Ensuring product information stays consistent across regulators, hospitals, distributors, and internal teams is critical to maintaining trust. Discrepancies can undermine confidence and slow operations.
Centralize, Validate, and Syndicate Your Medical Device Data
Manage your medical device data efficiently while ensuring compliance, accuracy, and audit readiness across global regulatory registries with the osapiens HUB for Medical Devices:
✓ Centralize Your Data: Collect all product information in one place, keeping internal teams, distributors, and hospitals aligned.
✓ Validate Automatically: Ensure your UDI and product data meet regulatory requirements before submission, minimizing errors and compliance risk.
✓ Syndicate Globally: Submit data efficiently to EUDAMED, GUDID, and other regulatory authorities worldwide.
✓ Accelerate Time-to-Market: Reduce friction in data exchange and bring new products to market faster.
✓ Audit-Ready & Traceable: Maintain a fully auditable history and ensure compliance with QMS and global standards.
Supported Registries and Data Networks
EUDAMED
- Align with EU requirements using BUDI-compliant submissions tailored to EUDAMED’s data structures.
- Simplify submissions for all company sizes with XLSX uploads for smaller inventories or API/XML for large catalogs.
- Maintain visibility and traceability of all EUDAMED entries and status updates in one platform.
Technology Integrations and Partners
Stay Ahead of Regulatory Requirements
Operate in a validated, QMS-compliant environment with the osapiens HUB for Medical Devices to exchange UDI data securely and compliantly between manufacturers, regulators, and trading partners.
Our in-house experts, who co-chair the EUDAMED IT Expert Group at MedTech Europe and contribute to the GS1 Global Healthcare Leadership Team, ensure your data management aligns with the latest regulations and industry best practices.
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Compliance Guides
How can medical device manufacturers manage regulatory product data more effectively? Access practical resources designed to help medical device manufacturers understand regulatory requirements and prepare their product data for global registries.
EUDAMED Compliance Made Simple – Your Guide to Successful Implementation
Get a practical overview of EUDAMED requirements and learn how to prepare, structure, and submit device data successfully.
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Mastering Global UDI Compliance - A practical Guide for Medtech Companies
Understand global UDI frameworks and learn how to structure, validate, and manage product data to meet regulatory requirements across markets.
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Featured Webinar
EUDAMED 2026: What Medical Device Manufacturers Must Do Now to Stay on the EU Market
EUDAMED becomes mandatory in May 2026. Learn how to prepare your UDI data, avoid compliance delays, and connect your systems to global registries.
Featuring experts from osapiens, PTC, MedTech Europe & GS1
01. April 2026, 5:00 PM - 6:00 PM (CET)
Register Now
osapiens HUB for Medical Devices
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Resource Center
Further Insights
Blog
Read time: 5 minutes
EUDAMED 2026: Why Late Movers Face Serious Compliance Risk
With the European Commission confirming the EUDAMED 2026 rollout, medical device manufacturers must prepare now to meet upcoming registration deadlines for new and existing devices.
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Whitepaper
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Product Information Management (PIM) in the Healthcare Industry
Discover how healthcare companies can meet strict product information requirements with the right processes and technology.
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Blog
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EUDAMED 2026: Key Steps for Medical Device Manufacturers
With the European Commission confirming the EUDAMED 2026 rollout, medical device manufacturers must prepare now to meet upcoming registration deadlines for new and existing devices.
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Case Study
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How PAJUNK® Streamlined Product Content Management with the osapiens HUB for Medical Devices
Discover how PAJUNK® turned slow, error-prone product data into a fully automated, regulation-ready system.
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Blog
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Understanding AusUDID: Australia's Unique Device Identification Database
With AusUDID, Australia is joining the global UDI ecosystem, adding a new regulatory requirement for companies supplying medical and IVD devices to the Australian market.
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Blog
Read time: 7 minutes
swissdamed Explained: Requirements, Deadlines, and What Medical Device Companies Should Do Now
swissdamed is Switzerland’s national medical device database, and manufacturers, authorized representatives, and importers must register their devices and company data before mandatory device registration begins in July 2026.
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